A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Recruiting
Phase 2
Phase 3
Interventional Study
Kidney Transplant Rejection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 526 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligibl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
* Participants with low to moderate immunological risk.
Exclusion Criteria:
* Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac deat…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT